GASTRODUODENAL TOLERANCE TO METHYLPREDNIS OLONE - ORAL VERSUS INTRAVENOUS ADMINISTRATION IN HEALTHY VOLUNTEER

Objectives: To endoscopically evaluate the tolerance of gastroduodenal mucosa to methylprednisolone given orally and intravenously. Methods: Thirty two healthy volonteers (age range 18-39 years) were divided ra ndomly into two groups of 16 each (8 males and 8 females). All were Ca ucasians, gave their informed consent and were considered normal after a complete clinical and laboratory work-up including gastroduodenal f ibroscopy. Methylprednisolone (500 mg) was administrated for three con secutive days at 9 a.m., orally in one group and intravenously in the second group. No other drugs were being taken and alcohol and smoking were prohibited from day 0 to day 11. Tolerance was evaluated on days 4 and 11 based on clinical examination, blood pressure, heart rate, or al temperature, body weight, blood and urine chemistry and by video-re corded gastroduodenal endoscopy. Two independent endoscopists, uninfor med of the patient's regimen, scored lesions from 0 (normal) to 5 (mor e than 25 lesions including at least 2 erosions). In case of abnormal findings, follow-up was continued to normalization. Results: Endoscopi cally detectable lesions (stage I) attributed to corticosteroid therap y were observed in 4 subjects in the oral group and in 5 in the intrav enous group. All regressed spontaneously. Duodenal lesions were observ ed only after oral administration while lesions of gastric mucosa were mostly found after intravenous administration. Systemic effects inclu ded abdominal pain after oral intake, 1 case of insomnia and bitter ta ste in the mouth after intravenous administration. Conclusions: These findings suggest that the effect of corticosteroid therapy, on the gas tric mucosa, is basically systemic, and on the duodenal mucosa, basica lly local. No severe manifestations were observed after high-dose meth ylprednisolone given orally or by intravenous injection.